Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

FRC 2018-02-28

VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag

Applicant STERIS Corporation

K-Number K173633

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GXY 2018-02-28

S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D

Applicant Everyway Medical Instruments Co.,Ltd

K-Number K173186

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IYN 2018-02-28

ALOKA ARIETTA 850

Applicant Hitachi Healthcare Americas Corporation

K-Number K173739

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LSR 2018-02-28

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack

Applicant Quidel Corporation

K-Number K173691

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CAF 2018-02-28

MC 300* Nebulizer

Applicant Trudell Medical International

K-Number K173367

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DCN 2018-02-28

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls

Applicant The Binding Site Group , Ltd.

K-Number K172868

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IYO 2018-02-28

Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)

Applicant Guangzhou Sonostar Technologies Co., Ltd.

K-Number K172750

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OAP 2018-02-28

REVIAN RED

Applicant Photonmd, Inc.

K-Number K173729

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LLZ 2018-02-28

CereMetrix Silver

Applicant Ceremetrix Corp

K-Number K173145

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DPS 2018-02-28

HeRO Symphony, HeRO ES, HeRO solo/duet

Applicant Medical Predictive Science Corporation

K-Number K180242

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JGS 2018-02-27

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)

Applicant Awareness Technology, Inc.

K-Number K171476

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KNS 2018-02-27

Rezum System

Applicant Nxthera, Inc.

K-Number K180237

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